NCT06095037

Brief Summary

This study will adopt the intervention of mindful yoga to improve the psychological well-being of older adults who discharged from hospital and their caregivers in Hong Kong.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
668

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Mar 2025Sep 2028

First Submitted

Initial submission to the registry

October 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

October 12, 2023

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Depression, Anxiety, and Stress Scale

    The total score ranges from 0 to 63. Higher score indicates higher level of depression, anxiety and stress

    Through study completion, an average of 12 weeks

Secondary Outcomes (8)

  • Five Facet Mindfulness Questionnaire

    Through study completion, an average of 12 weeks

  • Five Facet Mindfulness Questionnaire

    3 months follow-up

  • Five Facet Mindfulness Questionnaire

    6 months follow-up

  • The meaning in life scale

    Through study completion, an average of 12 weeks

  • The meaning in life scale

    3 months follow-up

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Mindful yoga

Behavioral: Mindful yoga

Control

ACTIVE COMPARATOR

Psychoeducation

Behavioral: Psychoeducation

Interventions

Mindful yogaBEHAVIORAL

12 week mindful yoga intervention

Intervention
PsychoeducationBEHAVIORAL

12 week psychoeducation sessions

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults discharged from hospital
  • older adults aged 65 years or above;
  • individuals who have been discharged from a local hospital within the previous 3 months who qualify for the Pilot Scheme on Support for Elderly Persons Discharged from Public Hospitals after Treatment and are receiving services from community support services;
  • individuals with no mobility issues or who have limited mobility but can access the intervention sites using a wheelchair and are capable of practicing mindful yoga, even if in a wheelchair; and
  • individuals who can understand Cantonese.
  • Caregivers:
  • living with older adults during the transition period from hospital to home.

You may not qualify if:

  • Older adults discharged from hospital
  • older adults diagnosed with depression, anxiety, or stress disorders by certified doctors;
  • older adults diagnosed with severe dementia;
  • homebound older adults who face difficulty attending the intervention sites; and
  • older adults having a tech-enabled Hospital Admission Risk Reduction Program for the Elderly (HARRPE) score \<0.17 or \>0.29.
  • Caregivers:
  • Family caregivers who have been diagnosed with severe mental health issues will be excluded from the proposed study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

  • Qi Wang

    Lingnan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaochen Zhou

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 23, 2023

Study Start

March 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Data without participants' privacy information will be shared

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The supporting documents will be shared June 30, 2024
Access Criteria
Anyone can access to the supporting documents

Locations